Pentasodium Pentetate About To Be Banned

Pentasodium Pentetate – crazy name, crazy molecule

Pentasodium pentetate is a chelating agent – something added to a formulation to bind with metal ions. This is useful because metal ions can affect stability. This one isn’t particularly widely used in cosmetics and personal care product.  It’s more of a laundry ingredient.  To be honest there is nothing much to date that has been particularly interesting about it. 

In the food industry, it is used to maintain the  appearance of food products. It is also used in some cosmetic and personal care products, such as shampoos and soaps, to improve their texture and stability.

In terms of safety, the US Food and Drug Administration (FDA) has deemed pentasodium pentetate as generally recognized as safe (GRAS) for use in food, and it has also been approved for use in cosmetics and personal care products by regulatory agencies around the world.  It is listed on the CosIng database without any restrictions for example.  It even gets a pass from the notorious scaremongers at the EWG, who give it their lowest risk rating.

Even the cleverest of chemists can’t tell whether a chemical is safe or not just by looking at its formula.  But there are some patterns, and this is not a material that you’d expect to fall into the dangerous category.

But it has somehow contrived to get itself banned in cosmetics.  It was reviewed by the European Chemical Agency, and they weren’t happy with the data supplied by the manufacturer. Consequently they’ve moved it onto the CMR list of materials suspected of being carcinogenic. 

The CMR listing system is a classification system used to identify and regulate chemicals that are carcinogenic (C), mutagenic (M), or toxic to reproduction (R). These chemicals are commonly referred to as “CMR substances.”

The classification of a chemical as a CMR substance is based on scientific evidence of its potential to cause cancer, genetic mutations, or harm to reproductive health. The evidence is typically obtained from laboratory tests on animals or humans, epidemiological studies, or other relevant scientific literature.  

Once a chemical is identified as a CMR substance, it may be subject to regulatory controls, such as restrictions on its use, labeling requirements, or even bans. The specific regulations depend on the jurisdiction and the level of risk associated with the chemical. The CMR listing system is used around the world, including the European Union, the United States, and Japan.  So this is quite a serious setback for anyone who is a fan of this material.

There was just one last possible way its use could continue.  In the EU, the use of CMR substances in cosmetic products is regulated by the Cosmetics Regulation (EC) No 1223/2009. Under this regulation, CMR substances are prohibited for use in cosmetic products unless they are subject to specific restrictions or exemptions.  In other words, if the European Commission judges that the risks don’t apply to cosmetics then it can give the material a pass. This makes sense – cosmetics are often only applied to the skin and many materials have very low penetration potential.   This hasn’t happened in this case. Anything containing it has to be off the shelves by the end of November this year.

While this is a bit of a nuisance, I don’t think it will be too troublesome to replace in cosmetic formulations. The old standby EDTA does the job just as well most of the time.

If you are a customer of ours and we have a product of yours that contains this material that we have on our database, we’ll be in touch shortly.  If you aren’t yet a customer, but you have some products that contain pentasodium pentatate now might be a good time to get in touch as we’ll be doing special prices for updating formulations.

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